Clearance Summary
RDP-2000 received FDA 510(k) clearance under submission number K813158, sponsored by Machlett Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1982-01-19.
- Submission: K813158
- Applicant / Sponsor: Machlett Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1982-01-19
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.